Background: Rupture has long been considered one of the key complications of silicone-gel breast implants. The incidence of rupture has been correlated with implant generation, and extensive data on current-generation breast implants, including prospective multicenter clinical trials, are now available from numerous sources.
Methods: Device-retrieval data from breast implant manufacturers were reviewed to identify common factors that likely contribute to rupture. The cumulative incidence of rupture from a prospective clinical study was estimated in multiple ways using the Kaplan-Meier method to demonstrate the need for a uniform calculation methodology.
Results: The complexity of identifying, analyzing, and understanding rupture is addressed, and the clinical management of rupture in older generation breast implants lacking highly cohesive gels and barrier layers is reviewed. The data suggest that iatrogenic damage is the most frequent cause of rupture. Data from one manufacturer’s prospective breast implant core study are presented to address the complexity of rupture-rate calculations—a single-time-point rupture rate varies from 9.0 to 12.2 percent, depending on which statistical parameters are used.
Conclusions: The significant contribution of iatrogenic damage to overall rupture rate suggests that rupture may be more often operator-related than device-dependent. In addition, there is a critical need to implement uniform statistical methodology using follow-up data only through the patient’s last magnetic resonance imaging scan, as rupture rates can vary greatly depending on the statistical methodology selected. Adoption of a uniform standard for rupture rate calculations would enable both patients and surgeons to base clinical decisions on more accurate and consistent information.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Santa Barbara, Calif.; and Springfield, Va.
From the Division of Plastic Surgery, David Geffen School of Medicine at the University of California, Los Angeles; Mentor Worldwide LLC; and LSCI.
Received for publication January 4, 2013; accepted May 13, 2013.
The Mentor prospective core studies referenced in this article were conducted adhering to International Conference on Harmonization Good Clinical Practice principles with the ethical principles that have their origin in the Declaration of Helsinki. Informed consent was obtained from each patient before enrollment. The trials are registered under the names “Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses,” Clinical Trials.gov identification number NCT00753922 (http://clinicaltrials.gov/show/NCT00753922); “Mentor Siltex Contour Profile Gel Mammary Prosthesis Clinical Trial (CPG),” Clinical Trials.gov identification number NCT00812097 (http://clinicaltrials.gov/ct2/show/NCT00812097); and “Safety and Effectiveness of Natrelle Cohesive Round Silicone-Filled Breast Implants,” Clinical Trials.gov identification number NCT00689871 (http://clinicaltrials.gov/ct2/show/NCT00689871).
Disclosure: The Mentor MemoryGel and MemoryShape Clinical Studies were sponsored by Mentor Worldwide LLC, Santa Barbara, California. Dr. Handel is a consultant to Mentor Worldwide LLC; however, he did not receive financial compensation for contributing to this article. Dr. Wixtrom is a consultant to Mentor Worldwide LLC. Dr. Garcia is an employee of Mentor Worldwide LLC.
Neal Handel, M.D., 225 West Pueblo Street, Suite A, Santa Barbara, Calif. 93105, firstname.lastname@example.org